Kornimate/medical-research-clean huggingface dataset:
safety of azli in children with cystic fibrosis (cf) and chronic pseudomonas aeruginosa in the lower airways

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: this was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (cf) and chronic pseudomonas aeruginosa (pa) infection in the lower airways using three 28-day courses of aztreonam for inhalation solution (azli) 75 mg three times daily, each followed by 28 days off azli. the total treatment duration was to be 6 months.


Eligibility criteria:
inclusion criteria: * diagnosis of cf as determined by the 1997 cf consensus conference criteria: * documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis test or * abnormal nasal transepithelial potential difference (npd) test or * a genotype with 2 identifiable mutations consistent with cf and * one or more clinical features consistent with cf. * documented positive lower respiratory tract culture for pa at the screening visit plus two documented positive lower respiratory tract cultures for pa within 12 months prior to study entry (must have been a minimum 3 months apart.) * clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of iv antipseudomonal antibiotics, oxygen supplementation, or hospitalization. exclusion criteria: * use of iv or inhaled antipseudomonal antibiotics within 14 days of study entry * presence of a condition or abnormality that would have compromised the participant's safety or the quality of study data, in the opinion of the investigator * history of sputum or throat swab culture yielding burkholderia spp. within 2 years prior to screening visit * history of hypersensitivity/adverse reaction to aztreonam * history of hypersensitivity/adverse reaction to beta-agonists * history of lung transplantation * administration of any investigational drug or device within 30 days prior to screening visit or within 6 half-lives of the investigational drug (whichever was longer) * hospitalization for pulmonary-related illness within 28 days prior to screening visit * changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit * changes in or initiation of hypertonic saline treatment within 7 days prior to screening visit; for subjects on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline was allowed * changes in antimicrobial, bronchodilator (bd), corticosteroid or dornase alfa medications within 7 days prior to screening visit; * changes in physiotherapy technique or schedule within 7 days prior to screening visit * abnormal renal or hepatic function results at most recent test within the previous 90 days

Keywords: cystic fibrosis cf pa pseudomonas aeruginosa azli aztreonam chronic pseudomonas aeruginosa
pre-biotics and probiotics for constipation in parkinson's disease

Conditions: Constipation

Summary: constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting parkinson's disease (pd) patients. unfortunately, limited treatment options have been investigated and are now available for the management of constipation in pd. preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in pd compared to placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of constipation according to roma iii criteria * complete bowel movements per week \<3 * total bowel movements per week \<6 * written informed consent exclusion criteria: * report of loose (mushy) or watery stool in the absence of laxative use * ongoing artificial nutrition * lactose intolerance * chronic inflammatory bowel disease * previous abdominal surgery * use of anti-cholinergics * use of antibiotics in the 6 weeks before baseline visit * radio- chemotherapy * cognitive decline (mini mental state examination \<27)
univu-guided vein of marshall ethanol infusion (marshall-merge)

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Summary: the study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of vein of marshall ethanol infusion (vomei), i.e., the conventional fluoroscopy-guided vomei and univu-guided vomei.

a total of 100 participants with persistent or longstanding persistent af who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive vein of marshall ethanol infusion (vomei). group 1: vomei guided by fluroscopy alone group 2: vomei guided by fluoroscopy and carto univu the intraprocedural major endpoints are the change in low-voltage area led by vomei (efficacy endpoint) and procedural complications (safety endpoint). the longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * sympathetic atrial fibrillation without previous ablation * persistent or long-standing persistent af * patients' willing to undergo catheter ablation and vomei exclusion criteria: * left atrial or left atrial appendage thrombus * lvef \<30% * cardiac surgery within 90 days * myocardial infarction within 90 days * pci or ptca within 90 days * thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism * atrial myxoma * congenital heart disease * pregnant or pregnant plan * acute or severe infection * creatine\> 221 μmol/l, or gfr \<30 ml/min/1.73 m. * unstable angina * blood-clotting or bleeding disorder * contraindication to anticoagulation * life expectancy less than 1 year * uncontrolled heart failure * uncontrolled malignant tumor * malformation of femoral vascular access * without consent
impacts of the indashyikirwa program on intimate partner violence in syria

Conditions: Intimate Partner Violence (IPV); Well-being/Quality of Life; Decision Making; Gender-Based Violence; Gender Equality; Gender Role; Empowerment

Summary: this study aims to evaluate the effectiveness of the indashyikirwa program in enhancing women's empowerment and reducing intimate partner violence (ipv) in conflict-affected communities in northeast syria. the intervention group will participate in the indashyikirwa ("agents of change") program, which includes a comprehensive couples' training module and access to safe spaces. the control group will not receive the indashyikirwa program. both intervention and control groups are beneficieries of small and medium enterprise (sme) support and vocational training (vt) to promote economic empowerment. the study employs a cluster-randomized controlled trial (crct) design. out of 30 pre-identified villages, 15 villages were randomly assigned to receive the indashyikirwa program and 15 villages will not receive the indashyikirwa program. the villages were located within the same sub-districts to ensure a balanced geographic distribution of the intervention. based on a power analysis with 80% power, at least 16 married couples from eligible sme and vt beneficiaries will be voluntarily enrolled in each village to receive the indashyikirwa intervention. similarly, 16 eligible sme and vt married couples from control villages will be enrolled using the same voluntary participation principle. to account for potential attrition, 20 couples per village will be initially enrolled, ensuring a robust sample size for analysis. this approach results in a total sample size of 600 couples (or 1,200 individual participants). the primary objective of this study is to assess the impact of indashyikirwa program on key outcomes, including the reduction in ipv, transformation of gender norms, enhancement of women's empowerment, improvements in intra-household dynamics, economic benefits to the household. data collection will involve structured surveys administered separately to both husbands and wives. surveys will be conducted at four time points: baseline, 2 months post-intervention, 12 months post-intervention, and 24 months post-intervention.


Eligibility criteria:
two levels of eligibility: 1. at the village level: * villages must be receiving the sme and vt programs by the implementing partners. * villages must have at least 16 eligible couples (married women and their husbands). 2. at the individual level: * women must be aged 18 or older. * women must be currently married and residing in the same household as their husbands. * women must be participants in the vocational training (vt) program and eligible for sme grants. exclusion criteria * villages or individuals not meeting the inclusion criteria. * women who are unmarried, divorced, or widowed. * women who do not reside with their husbands in the same household.

Keywords: syria heterosexual couple gender transformative approach conflict settings randomised controlled trial couple curriculum
impact of chemokine receptor 5 (ccr5) inhibition on sarcoidosis immunophenotypes

Conditions: Sarcoidosis

Summary: the study hypothesizes that inhibition of the receptor ccr5 by maraviroc will diminish inflammation in patients with sarcoidosis. subjects with active sarcoidosis will first undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline analysis. they will then receive the drug maraviroc for 6 weeks duration. they will then undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for analysis following maraviroc treatment.

the investigators hypothesize that inhibition of ccr5 by maraviroc may have a beneficial immunomodulatory effect on the granulomatous inflammation of pulmonary sarcoidosis. the specific aim of this proposal is the investigate the effect of ccr5 inhibition on the trafficking of mononuclear cells to the lung, skin, peripheral blood in subjects with active sarcoidosis exposed to the ccr5 inhibitor, maraviroc. a second aim will be to isolate by cell sorting cluster of differentiation 4 (cd4)+ccr5+ t cells for amplified gene expression profiling before and after ccr5 inhibition, experiments the investigators believe will elucidate genes associated with downstream activation and inhibition of ccr5 receptor function.

Eligibility criteria:
inclusion criteria: 1. histologically proven sarcoidosis from any site (noncaseating granulomas without other causes). 2. diagnosis of active sarcoidosis (sec. 5.5.4.t) clinical stage ii by chest x-ray (cxr). 3. forced vital capacity (fvc) \>45% and diffusing capacity for carbon monoxide (dlco) \>50% of predicted values. 4. evidence of active sarcoidosis (see criteria above) 5. able and willing to complete all study procedures (e.g., bronchoscopy, post-drug surveillance) 6. age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety not established). 7. not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids, tumor necrosis factor alpha (tnf-a) blockade) 8. liver function (transaminases, bilirubin), coagulation (international normalized ratio (inr), partial thromboplastin time (ptt), platelet count), blood urea nitrogen (bun), creatinine, and white blood count (wbc) within normal limits. 9. if female: negative pregnancy test, agreement to use reliable contraception if of childbearing potential 30 days prior and for 30 days after study completion (drug safety during pregnancy not established). 10. negative hiv and hbsag tests exclusion criteria: 1. diagnosis of infection based upon clinical evaluation and/or microbial testing. 2. the diagnosis of any disease involving the heart, lungs, liver (hvc), kidney, hematologic, endocrine, or gl systems which, in the judgment of the pi, would pose an undue risk to the subject if they participated in this study. this includes but is not limited to diabetes, uncontrolled hypertension, liver disease (hvc), or history of malignancy. 3. medications that will either inhibit or induce cyp3a4 (including st john's wort)

Keywords: sarcoidosis ccr5 inhibition maraviroc
survey of health preferences in cancer patients (qaly-cancer)

Conditions: Breast Cancer; Colorectal Cancer

Summary: this study will evaluate health utilities in patients with breast or colorectal cancer.

the cost-utility analysis (cua) is an increasingly used method to help health decision-maker. the cua uses the quality adjusted life years (qaly) that combines the length of life with the health related quality of life (hrqol) into a single score. in quebec, no qaly calculation tool has been adapted to its linguistic and socio-cultural context, neither for its general population nor for a particular subpopulation, like patients with cancer. the objectives will be to analyze the extent of the divergence in terms of health states utilities between the general population and patients with breast or colorectal cancer; to develop a qaly preference weights dataset for patients with cancer; to perform "mapping" with different health-related quality of life questionnaires by correlating sf6dv2 with eq-5d-5l, eortc qlq-c30 and fact- g. the data will be collected with a self-administered online survey. patients outcomes will be measured at the beginning of the chemotherapy treatment cycle and about 8 days after the start of chemotherapy. health utilities will be measured with a hybrid method using the time-trade-off (tto) and the discrete experimental choice (dce) method using sf6dv2 questionnaire for health states.

Eligibility criteria:
inclusion criteria: * to be 18 years of age or older; * to reside in quebec; * have already had a chemotherapy treatment cycle; * be on the eve of a new round of chemotherapy treatment; * have breast or colorectal cancer exclusion criteria: * being over 80 years of age; * not be able to complete a computer questionnaire; * can not read or write in french; * not be able to sign a consent form; * the only treatment offered is surgery; * presence of metastases to the brain; * patient with delirium, psychosis or severe depression (i.e. chronic condition with treatment)

Keywords: qaly cost-utility analysis time-trade-off method discrete choice experiment method
lactobacillus reuteri for the treatment of infantile colic:

Conditions: Infantile Colic; Crying

Summary: infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. the crying typically starts in the first few weeks of life and ends by 4-5 months of age. the condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. recently, it has been suggested that probiotics may offer some benefit.this is based on the results of one open randomized controlled trial. in this trial, 83 breast-fed infants with colic defined as \>3 hours of crying on \>3 days/week were randomly allocated to receive lactobacillus reuteri dsm 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. mothers followed a cow's milk free diet. by day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). in addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. no adverse effects of l. reuteri were reported. although the mechanism of action of l. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. however, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. another limitation of the study is the lack of a true placebo group. given these consideration a new study is proposed that is aiming to overcome these limitations.

eligible infants will be randomly assigned to receive either l. reuteri 108 cfu per day or placebo. both the active treatment and placebo will be taken orally, 1 times daily, for 21 days. all infants are eligible for screening. if a patient appears to meet the criteria for enrollment and express interest in the study, cow's milk elimination diet will be prescribed for 1 week to a breastfeeding mother (and to an infant, in case of formula fed infants). care givers will be asked to record for 1 week symptoms of colic. children fulfilling inclusion criteria will be asked to participate in the study.

Eligibility criteria:
inclusion criteria: * full-term infants age \<5 months * infantile colic (\>3 hours of crying on \>3 days in the week) within 7 days prior to enrollment * exclusive or predominant (\>50%) breastfeeding * informed consent exclusion criteria: * acute or chronic illness * gastrointestinal disorders * use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.

Keywords: infantile colic lactobacillus reuteri duration of crying
the effect of frequent self measurements of blood pressure on the control of hypertension

Conditions: Hypertension

Summary: despite knowledge regarding the importance of controlling patients' blood pressure (bp) only 30% of treated patients achieve bp goals. our objective was to determine the effect of frequent self measurements of bp in the patients' natural environment as a mean to improve bp control. our hypothesis was that frequent measurements of bp will reduce mean bp levels.


Eligibility criteria:
inclusion criteria: * signing an informed consent form * having a diagnosis of hypertension for more than one year according to patients'records. * receiving at least one medication for hypertension * a reasonable understanding of hebrew * an ambulatory state enabling regular visits to a primary physician in the community and self-measurement of hypertension using the electronic device exclusion criteria: * lack of willingness to participate in the study.known arrhythmia * malignant disease * poor understanding of hebrew

Keywords: 24 hour ambulatory blood pressure measurement mean blood pressure wrist manometer frequent measurement
quality of life and sexual function in vaginal aplasia patients after davydov procedure

Conditions: Mayer Rokitansky Kuster Hauser Syndrome; Quality of Life; Sexual Function Disturbances

Summary: mayer-rokitansky-kuster-hauser(mrkh) syndrome is described as absence or underdevelopment of vagina and uterus. this condition is extremely rare congenital malformation that affects one in every 5000 female births. medical management of mrkh syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. in vietnam, since 2014, davydov technique has been used to create neovagina for patients with mrkh syndrome at tu du hospital which is the biggest obstetric and gynecological hospital in south of vietnam. however, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. the objective of this study is to assess the quality of life, the psychological impact and the sexual function of vietnamese women with mrkh syndrome after davydov surgical procedure.

this study will be conducted at tu du hospital, ho chi minh city, vietnam. female patients diagnosed with mayer-rokitansky-kuster-hauser (mrkh) syndrome were performed the davydov procedure to create neovagina at the anaesthesia and intensive care department, tu du hospital. based on the department of anaesthesia and intensive care data, a list of potentially eligible patients who underwent davydov surgery at least six months was made. because of the impact of the covid 19 pandemic, the patients could not come to the hospital, so the research team decided to interview the participants online. according to this list, patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the davydov procedure. the informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment. on appointment day, the investigator will make group telecommunication by an application on cell phone or computer. efficacy of davydov procedure according to the functional aspect: the psychological doctors assess the impact of patient's neovagina on life and sexual function through questionnaires involving world health organization quality of life scale (whoqol-bref), female sexual function index (fsfi) and self-composed qualitative questionnaire. the interview with a patient will be held individually and conducted by the psychological doctor. the participants will be requested to record the conversation. because mrkh syndrome is a rare condition, the investigators take all patients who are suitable to inclusion criteria and accept participating in our research.

Eligibility criteria:
inclusion criteria: * aged equal or more than 18. * diagnosed vaginal agenesis and underwent davydov procedure to create neovagina at least 6 months. * able to listen, understand and answer questions. exclusion criteria: * disagreed to participate the research. * having any conditions that make patient unable to listen, understand and answer questions. * having psychological disturbance.
a-priori versus provisional heparin on radial artery occlusion after transradial coronary angiography and patent hemostasis

Conditions: Coronary Artery Disease

Summary: the provisional heparin therapy on radial artery occlusion after transradial coronary angiography and patent hemostasis (pharaoh) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.

transradial access use for coronary angiography and intervention is increasing. its efficacy in lowering access site complications, as well as increased patient comfort, has been proven unequivocally. one of the complications of transradial access is radial artery occlusion (rao) that occurs with a variable incidence. it is population specific, with a higher prevalence in subsets, such as women, and patient's with small radial arteries. rao is also known to be higher at hospital discharge and radial recanalization may spontaneously occur at later times. it is usually asymptomatic. its main adverse impact is by limiting future transradial access from that radial artery. since most of the patient's with atherosclerotic vascular disease may undergo several invasive procedures during their lifetime, prevention of rao is of paramount importance. heparinization, during the procedure, has been shown to be of benefit in lowering the incidence of rao. maintaining patency of the radial artery during hemostasis, has also been shown to be effective in prevention of rao following transradial access. as maintenance of flow has potent antithrombotic effect, it is unclear whether systemic anticoagulation is still required in all cases. in some cases, it would be preferable to avoid heparin administration prior to coronary angiography. it is currently unknown whether it would be safe to refrain from heparin administration in case of transradial catheterization and patent hemostasis technique.

Eligibility criteria:
inclusion criteria: * all diagnostic cardiac cath patients exclusion criteria: * warfarin therapy * previous ipsilateral tra * lack of consent * abnormal (type d) barbeau test * scleroderma * thrombocytopenia * or other contraindications to heparin

Keywords: radial artery occlusion hemostasis coronary intervention radial approach